Enhanced Recovery After Surgery in Oblique Lumbar Interbody Fusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-12

Study Completion Date

2024-02-28

Brief Summary

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This study is a randomized controlled non-inferiority trial designed to evaluate the impact of implementing the 'Early Recovery After Surgery Clinical Pathway (ERAS CP)' on patient-reported pain levels at the time of discharge following Oblique Lumbar Interbody Fusion (OLIF) surgery

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Detailed Description

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Currently, the effectiveness of the ERAS has been widely confirmed in patients undergoing colorectal resection, and it has been verified to reduce length of hospital stay and complications. However, the ERAS protocol for lumbar fusion surgery is based on a few retrospective studies and remains a consensus statement. Recent retrospective studies targeting patients undergoing lumbar fusion surgery reported that implementing ERAS could accelerate post-operative functional recovery and reduce hospital stay. However, there is still a lack of high-quality evidence based on prospective studies.

Lumbar fusion surgery is known for potentially leading to severe postoperative pain, which poses challenges in consistently applying ERAS components, such as early ambulation or active oral feeding, after surgery. In light of this, the present study aims to validate the non-inferiority of pain levels at discharge within the ERAS group and to reconfirm the effects of ERAS as observed in retrospective studies.

Patients admitted for OLIF will be consecutively screened for eligibility. A computer-generated block randomization will be executed at a 1:1 ratio. In the ERAS group, patients will receive comprehensive education about the treatment process, and a clinical pathway that includes active ambulation and pain control will be protocolized and implemented. Should non-inferiority be demonstrated in both intent-to-treat and per-protocol analyses, non-inferiority will be declared.

Conditions

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Enhanced Recovery After Surgery Spinal Fusion Lumbar Spinal Stenosis Lumbar Spondylolisthesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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ERAS group

The experimental group will be implemented with the ERAS Clinical Pathway (ERAS CP)

Group Type EXPERIMENTAL

Enhanced Recovery After Surgery program for Oblique Lumbar Interbody Fusion

Intervention Type BEHAVIORAL

In the ERAS CP group, the components of the ERAS are protocolized and implemented as a clinical pathway

Control group

The control group will not be implemented with the ERAS CP

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Enhanced Recovery After Surgery program for Oblique Lumbar Interbody Fusion

In the ERAS CP group, the components of the ERAS are protocolized and implemented as a clinical pathway

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Lumbar degenerative disease, requiring interbody fusion of 1-2 segments between L2 and S1
2. Capability of independent (or assisted) ambulation for at least 30 minutes with

1. Taking intermittent breaks
2. Enduring any discomfort
3. Voluntary informed consent to participate in the study.

Exclusion Criteria

1. Previous history of lumbar interbody fusion
2. Manual Muscle Testing grade 3 or below
3. Neuropsychiatric disorders such as major depressive disorder
4. Musculoskeletal disorders other than lumbar degenerative diseases (inflammatory, myopathic, infections, etc.)
5. Diagnosis of malignant neoplasm
6. Refusal to participate in the study

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No